Comparison · NCT02561273-sae
Treatment (10 mg Lenalidomide) vs Treatment (15 mg Lenalidomide): serious adverse events
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
2 sourcestrial-comparisons-2026-03-23-0.1.0
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ConductScience Library. Treatment (10 mg Lenalidomide) vs Treatment (15 mg Lenalidomide): serious adverse events. Trial comparisons, record NCT02561273-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT02561273-sae
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Measures6
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
| Measure | Value | 95% interval, lower | 95% interval, upper | Method | Note |
|---|---|---|---|---|---|
| Risk in group 1 | 0.359 | 0.227 | 0.516 | wilson | |
| Risk in group 2 | 0.5 | 0.15 | 0.85 | wilson | |
| Risk difference, group 1 minus group 2 | -0.141 | -0.515 | 0.242 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.718 | 0.247 | 2.08 | log | |
| Odds ratio, group 1 over group 2 | 0.56 | 0.0709 | 4.42 | log | |
| Number needed to treat, for one fewer participant with a serious adverse event on Treatment (10 mg Lenalidomide) than on Treatment (15 mg Lenalidomide) | 7.09 | from the risk difference interval | the interval includes no difference |
Source ClinicalTrials.gov
Groups2
Neither group, or both, names a comparator, so the groups keep ClinicalTrials.gov's order.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code |
|---|---|---|---|---|---|
| Group 1 | Treatment (10 mg Lenalidomide) | Patients receive cyclophosphamide IV, doxorubicin hydrochloride IV and vincristine sulfate IV on day 1, etoposide IV over 30-60 minutes on days 1-3, prednisone PO on days 1-5, and lenalidomide PO on days 1-10. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity. Patients responding after 6 courses of treatment may then undergo an autologous stem cell transplant or receive maintenance lenalidomide at the discretion of the physician or patient choice as follows:~TRANSPLANT: Patients undergo autologous stem cell transplant per standard of care.~MAINTENANCE LENALIDOMIDE: Patients receive lenalidomide PO on days 1-21. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.~Autologous Hematopoietic Stem Cell Transplantation: Undergo autologous stem cell transplant | 14 | 39 | EG000 |
| Group 2 | Treatment (15 mg Lenalidomide) | Patients receive cyclophosphamide IV, doxorubicin hydrochloride IV and vincristine sulfate IV on day 1, etoposide IV over 30-60 minutes on days 1-3, prednisone PO on days 1-5, and lenalidomide PO on days 1-10. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity. Patients responding after 6 courses of treatment may then undergo an autologous stem cell transplant or receive maintenance lenalidomide at the discretion of the physician or patient choice as follows:~TRANSPLANT: Patients undergo autologous stem cell transplant per standard of care.~MAINTENANCE LENALIDOMIDE: Patients receive lenalidomide PO on days 1-21. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.~Autologous Hematopoietic Stem Cell Transplantation: Undergo autologous stem cell transplant | 2 | 4 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
Adverse events were collected from time of consent until 30 days post after the last administration of study drug (lenalidomide). For subjects going on to transplant after Len-CHOEP treatment this was approximately 5 months. For subjects going on the the maintenance len treatment instead of transplant upto an additional 1 year of maintenance lenalidomide treatment was allowed. (17 months total)
Source ClinicalTrials.gov
Trial
- Title
- Combination Chemotherapy & Lenalidomide in Newly Diagnosed Stage II-IV Peripheral T-cell Non-Hodgkin's Lymphoma
- NCT number
- NCT02561273
- Phases
- PHASE1, PHASE2
- Conditions
Anaplastic Large Cell Lymphoma, ALK-Negative, Anaplastic Large Cell Lymphoma, ALK-Positive, Hepatosplenic T-Cell Lymphoma, Peripheral T-Cell Lymphoma, Not Otherwise Specified, Stage II Angioimmunoblastic T-cell Lymphoma, Stage II Enteropathy-Associated T-Cell Lymphoma, Stage III Angioimmunoblastic T-cell Lymphoma, Stage III Enteropathy-Associated T-Cell Lymphoma, Stage IV Angioimmunoblastic T-cell Lymphoma, Stage IV Enteropathy-Associated T-Cell Lymphoma
- Interventions
Autologous Hematopoietic Stem Cell Transplantation, Cyclophosphamide, Doxorubicin Hydrochloride, Etoposide, Laboratory Biomarker Analysis, Lenalidomide, Peripheral Blood Stem Cell Transplantation, Prednisone, Vincristine Sulfate
- Lead sponsor
- University of Nebraska
- Results first posted
- 2021-06-18
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT02561273?tab=results
Source ClinicalTrials.gov
Source
- Release
- trial-comparisons-2026-03-23-0.1.0
- Release manifest SHA-256
- f66225897fbf258b57ea10bdacfd0347d3cdfda93f7f5685234b7e06ea36fa57
- AACT copy
- 2026-03-23
- Tables read
- outcome_counts.parquet, outcome_measurements.parquet, outcomes.parquet, reported_event_totals.parquet, reported_events.parquet, result_groups.parquet, studies.parquet, ctgov_trial.parquet
Source ClinicalTrials.gov
Sources 2
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions. The measures are ConductScience's calculation from them.
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